Practice Guidelines for Opioid Substitution Treatment in New Zealand 2008 Practice Guidelines for Opioid Substitution Treatment in New Zealand 2008
Citation: Ministry of Health. 2008. Practice Guidelines for Opioid Substitution Treatment in New Zealand 2008. Wellington: Ministry of Health. Cover photo kindly provided by Dmitri Kotelevski Published in December 2008 by the Ministry of Health PO Box 5013, Wellington, New Zealand ISBN 978-0-478-31857-9 (print) ISBN 978-0-478-31858-6 (online) HP 4713 This document is available on the Ministry of Health s website: http://www.moh.govt.nz ii Practice Guidelines for Opioid Substitution Treatment in New Zealand 2008
Foreword Practice Guidelines for Opioid Substitution Treatment in New Zealand 2008 contains practical and evidence-based advice for clinicians on best practice for clinically assessing, treating and also providing psychosocial support to clients with opioid dependence. They replace the guidelines that were published in 2003. The new guidelines encompass a number of significant themes and important developments that have occurred over the last five years, including: the approval for the prescription of opioid substitution medication to clients/tangata whai ora entering prison who were already receiving opioid substitution treatment in the community the resolution to eliminate services waiting lists, hence requiring the introduction of interim prescribing as one means of managing demand the strong emphasis on shifting practice from maintenance treatment to actively supporting clients/tangata whai ora to plan for their own wellness and recovery, free of opioid substitution medication the key focus on the timely transitioning of clients/tangata whai ora to primary health care services, recognising the new opportunities that now exist with Primary Health Organisations (PHOs) agreeing to provide services to people who have addictions. These guidelines also take into consideration the prescription of alternative pharmacotherapies to methadone, some of which, while not subsidised, may be self-funded by clients. I take this opportunity to acknowledge the role that the National Association of Opioid Treatment Providers (NAOTP) fulfils in providing leadership, advice and support to services and to express gratitude to that group and others who have contributed to these revised guidelines. It is a very important step forward that clients/tangata whai ora and providers of opioid substitution treatment programmes are recognising and acting upon the need to move from maintenance-focused to recovery-focused treatment and that this is strongly endorsed in these revised guidelines. Dr David Chaplow Director of Mental Health Practice Guidelines for Opioid Substitution Treatment in New Zealand 2008 iii
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Contents Foreword... iii Introduction... Māori... 1 Sector standards... 1 Cultural diversity... 1 Opioid Substitution Treatment in New Zealand... 2 1.1 Key principles of effective opioid substitution treatment... 2 1.2 Objectives of opioid substitution treatment... 2 1.3 Specialist opioid substitution treatment services... 3 1.4 Framework of opioid substitution treatment services... 3 2 Entry into Opioid Substitution Treatment Services... 4 2.1 Assessment and suitability... 4 2.2 Delaying entry to opioid substitution treatment... 5 2.3 Special client groups... 6 2.3.1 Priority admissions... 6 2.3.2 Clients/tangata whai ora under 18 years of age... 6 2.4 Informed consent and treatment information... 7 2.5 Fitness to drive and operate machinery... 7 2.6 Contraindications to opioid substitution treatment... 8 2.7 The treatment plan... 8 3 Commencing Treatment... 0 3.1 Induction...10 3.2 The starting dose of methadone...10 3.3 The starting dose of buprenorphine...11 3.4 Induction and blood-borne viruses...12 3.5 Stabilisation...12 4 Ongoing Opioid Substitution Treatment... 4 4.1 Methadone doses...14 4.2 Buprenorphine doses...14 4.3 Maximum doses...14 4.4 Transferring from methadone to buprenorphine...15 4.5 Transferring from buprenorphine to methadone...15 4.6 Treatment reviews...16 4.6.1 Reviews by the prescribing specialist service doctor...16 Practice Guidelines for Opioid Substitution Treatment in New Zealand 2008 v
4.6.2 Reviews by the key worker...16 4.6.3 Reviews by a case management team...17 4.7 Monitoring drug use...18 4.7.1 Urine screening...18 4.7.2 Self-reporting...18 4.7.3 Screening for buprenorphine...18 4.8 Prescribing process...19 4.9 Takeaway doses...19 4.9.1 Safety requirements for dispensing...21 4.9.2 Special circumstances for granting additional takeaways...21 5 Promoting Wellness and Recovery through Case Management and Psychosocial Interventions... 22 5.1 Case management and co-ordination of care...22 5.2 Psychosocial interventions...23 5.2.1 Providing psychosocial interventions to clients/tangata whai ora in prisons...24 6 Transfers to other Specialist Services and to the Primary Health Care Sector... 25 6.1 Transfers between specialist services...25 6.2 Transfers from overseas...25 6.3 Transfers from the specialist service to the primary health care sector...26 6.4 Requirements of GPs who are accepting a transfer from a specialist service...27 6.5 Specific requirements of approved/gazetted GPs...27 6.6 Transfers between GPs...28 7 Specific Clinical Situations... 29 7.1 Replacement doses...29 7.2 Reintroducing methadone after missed doses...29 7.3 Measuring methadone serum levels...29 7.4 Split methadone dosing...30 7.5 Notice of prescription changes...30 7.6 Travel arrangements...30 7.7 Managing overdoses...31 7.7.1 Methadone overdose...31 7.7.2 Buprenorphine overdose...31 7.7.3 Consumption of methadone or buprenorphine by a child and management of intoxication...32 7.8 Managing ongoing drug use...32 7.8.1 Continued opioid use...33 vi Practice Guidelines for Opioid Substitution Treatment in New Zealand 2008
7.8.2 Benzodiazepine use...33 7.8.3 Tobacco use...34 7.8.4 Restriction notices...34 7.9 Managing side effects...35 7.9.1 Methadone...36 7.9.2 Buprenorphine...36 7.10 Clients/tangata whai ora who present intoxicated...36 7.11 Ageing clients/tangata whai ora...36 7.12 Pregnancy, breastfeeding and opioid substitution treatment...37 7.12.1 Methadone and pregnancy...37 7.12.2 Methadone and breastfeeding...38 7.12.3 Buprenorphine in pregnancy and breastfeeding...39 7.13 Needs of children of parents on OST...39 7.14 Pain management...39 7.14.1 Acute and surgical pain...39 7.14.2 Chronic non-malignant pain...40 7.15 Coexisting mental health issues...41 7.16 Blood-borne viruses...41 7.17 Dental problems...42 7.18 Methadone and risk of QTc prolongation...42 8 Ending Opioid Substitution Treatment... 43 8.1 Planned withdrawal...43 8.2 Suggested methadone reduction schedule...43 8.3 Suggested buprenorphine reduction schedule...44 8.4 Involuntary withdrawal...44 8.5 Last dose...46 8.6 Transferring to naltrexone...46 9 Clinical and Administrative Expectations of Specialist Opioid Substitution Treatment Services... 47 9.1 Treatment outcomes...47 9.2 Staffing...47 9.2.1 Level of training...48 9.3 Record keeping...49 9.4 Reporting requirements...49 9.5 Rights of the client/tangata whai ora...50 9.6 Complaints procedure...50 9.7 Safety requirements of specialist services...51 Practice Guidelines for Opioid Substitution Treatment in New Zealand 2008 vii
9.8 Local protocol requirements...51 9.9 External review...52 0 Other Opioid Substitution Medicines Used in New Zealand... 53 10.1 Introduction...53 10.2 Buprenorphine...53 10.2.1 Duration of action...54 10.2.2 Withdrawal syndrome...54 10.2.3 Drug interactions...54 Pharmacist Dispensing... 55 11.1 Shared responsibilities of pharmacists and prescribers...55 11.2 Methadone formulation...56 11.3 Procedures for dispensing and administration...56 11.4 Administering consumed doses...57 11.5 Administering buprenorphine...57 11.6 Takeaway doses...58 11.7 Delivery of methadone or other opioid substitute medicine...58 11.8 Telephoned methadone prescriptions and authorisation of takeaway doses...58 11.9 Cancellation of administered or dispensed doses...59 11.10 Risk management...59 11.11 Missed doses...60 11.12 Incorrect dosing...60 11.12.1 Reduced doses...60 11.12.2 Increased doses...60 11.12.3 Incorrect doses of buprenorphine...61 11.13 Managing difficult behaviour...61 2 Application for Approval to Offer Opioid Substitution Treatment... 62 12.1 Introduction...62 12.2 Approval of opioid substitution treatment services...62 12.2.1 The criteria...63 12.3 Existing services obligations...63 12.4 Medical practitioners working under authority...63 12.5 Application for approving/gazetting medical practitioners...64 12.6 Obligations of specialist services and approved medical practitioners to GPs working under authority...65 12.7 Revocation of authority...65 Appendix : Glossary... 66 viii Practice Guidelines for Opioid Substitution Treatment in New Zealand 2008
Appendix 2: Misuse of Drugs Act 975 s24... 68 Treatment of persons dependent on controlled drugs...68 Appendix 3: Pharmacology and Pharmacokinetics of Methadone and Buprenorphine... 70 Opioid pharmacology...70 Methadone...70 Buprenorphine...71 Opioid pharmacokinetics...71 Methadone...71 Buprenorphine...71 Methadone and buprenorphine and coexisting medical problems...72 Opioid withdrawal...72 Appendix 4: Drug Interaction Associated with Opioids... 73 Medicinal interactions...73 Some important drug interactions with methadone and buprenorphine...73 Appendix 5: Relevant Legislation and Codes of Practice... 75 Legislation and codes...75 Ministry of Health and other relevant guidelines...75 Professional codes of ethics and standards of practice...76 Current sector standards and audits...76 Appendix 6: Application Forms for Misuse of Drugs Act 975 s24... 77 References and Bibliography... 8 Practice Guidelines for Opioid Substitution Treatment in New Zealand 2008 ix
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Introduction These practice guidelines have been revised to replace the Opioid Substitution Treatment: New Zealand Practice Guidelines from 2003. They have been shaped from consultation with the National Association of Opioid Treatment Providers (NAOTP), the work of a reference group, research into material from similar guidelines and regional protocols, and from the valuable feedback of those who either attended focus group meetings in Wellington, Christchurch and Auckland or participated in teleconference focus group discussions as well as others who made written and/oral submissions. Focus meetings for clients/tangata whai ora were also held in both Christchurch and Auckland, and their feedback has contributed to the development of these guidelines as well. In addition, in 2006, the Department of Corrections revised its methadone treatment policy to allow all prisoners who were on a specialist opioid substitution programme before entering prison to be maintained on opioid substitution while in prison. The policy, The Prison Opioid Substitution and Managed Withdrawal Programme was reviewed in 2007. Māori Sector standards The policies and procedures of all alcohol and other drug treatment services need to reflect the requirements of the various relevant sector standards that will satisfy the provisions of the Health and Disability Services (Safety) Act 2001. They also need to be assessed with a view to what they offer the service in terms of ensuring clinical and cultural safety of staff and clients/ tangata whai ora as well as delivering services effectively. It is noted that funding contracts and New Zealand health and service sector standards require not only that the principles of the Treaty of Waitangi be expressed in policy but that Māori issues (including the Treaty) also be clearly demonstrated. Cultural diversity Māori are a varied population. Effective and relevant clinical management or treatment strategies need to recognise and be influenced by cultural and clinical factors and processes that support positive attitudes and behaviour in the aim of improving client health and welfare. Te Puāwaiwhero: The Second Māori Mental Health and Addiction National Strategic Framework 2008 2015 provides a clear direction for services to support Māori. Practice Guidelines for Opioid Substitution Treatment in New Zealand 2008
Opioid Substitution Treatment in New Zealand. Key principles of effective opioid substitution treatment Opioid substitution treatment (OST) in New Zealand is underpinned by the principles of: engagement, cultural considerations, wellbeing, motivation, assessment, management and integrated care. Service provision will include a range of accessible, evidence-based interventions that address physical, psychological and social functioning. Specialist services work toward reducing the stigma of opioid dependence by encouraging social inclusion and providing culturally relevant, responsive and non-judgemental OST programmes. Clients/tangata whai ora on OST have the right to receive the same quality of care as other health care consumers. Clients/tangata whai ora aspire to lead healthy and fulfilling lives. The continuum of care in OST will range from harm reduction (the aim being to reduce harm associated with opioid and other drug use) to recovery (broadly, a process whereby clients/ tangata whai ora are assisted to reach their full potential, with recovery not necessarily involving abstinence). Whānau ora and family inclusive practice is important in the delivery of OST. Client/tangata whai ora involvement is supported at all levels and in all aspects of OST service design, delivery, planning and evaluation. Specialist services support the movement of stabilised clients/tangata whai ora to the care of the primary health care sector and maintain functional links with GP prescribers and other relevant people involved in a client s/tangata whai ora s OST..2 Objectives of opioid substitution treatment In New Zealand, the objectives of OST, which line with the National Drug Policy (2007 2012), are to improve the health of New Zealanders by preventing and reducing the health, social and economic harms that are linked to the use of opioid drugs, and, in particular, to: contribute to improving the health, psychological and social functioning and wellbeing of clients/tangata whai ora and their families, including dependant children reduce the spread of infectious diseases associated with injecting drug use, especially hepatitis B and C and HIV/AIDS reduce the mortality and morbidity resulting from the misuse of opioid drugs assist individuals to achieve a successful withdrawal from opioids reduce episodes of other harmful drug use reduce crime associated with opioid use assist with recovery from opioid dependence and withdrawal from methadone, or other opioid substitute medicine, if appropriate and desired by the client/tangata whai ora. 2 Practice Guidelines for Opioid Substitution Treatment in New Zealand 2008
Not all these objectives will be achieved with each person dependent on opioids or to the same degree in each treatment setting. However, the aim is to reduce the risk of drug-related harm, as much as circumstances allow, for each person and for the community by minimising withdrawal symptoms, reducing opioid drug craving and blocking the euphoric effects of other opioids. All OST providers need to balance these objectives, within the resources available, with staff and client/tangata whai ora safety factors while maximising the client s/tangata whai ora s opportunities to recover from problem opioid use..3 Specialist opioid substitution treatment services Specialist opioid substitution treatment services are specified by the Minister of Health under section 24 of the Misuse of Drugs Act 1975 (see Appendix 2) and notified in the New Zealand Gazette. They are, unless there are exceptional circumstances and subject to the approval of the Director of Mental Health, the entry point for all people requiring treatment of severe opioid dependence with a controlled drug. The roles of specialist opioid substitution services include (but are not limited to): comprehensive alcohol and other drug assessment treatment planning within an integrated and holistic model and with a recovery focus stabilisation on an adequate dose of methadone or other opioid substitution medicine provision of specialist interventions to minimise the harms associated with opioid and other drug use and assist clients/tangata whai ora to make behavioural changes and lifestyle improvements transfer of stabilised clients/tangata whai ora to the care of GPs treatment and management of people who are unsuitable for transfer to GP care provision of appropriate psychosocial support and liaison services screening, advice and treatment, or referral for co-existing medical disorders with particular reference to those related to intravenous drug use and protracted opioid use assessment and treatment (or referral for treatment) of coexisting mental health disorders consultation, liaison and referral to allied professionals in other health care and social service roles, including peer support and advocacy services..4 Framework of opioid substitution treatment services Opioid substitution specialist services are currently provided through 17 District Health Boards (DHBs) and one non-government organisation. The specialist service is the entry point for clients/ tangata whai ora requiring initial assessment and stabilisation. Medical staff within specialist services and a number of GPs are authorised (by the specialist services) to prescribe opioid substitution. Some GPs are authorised independently and in some instances are authorised to supply specific services. In such cases, the Ministry of Health (the Ministry) specifies the services to be provided. The Ministry supports the entry point to any authorised or gazetted opioid substitution treatment to be through the specialist service. Practice Guidelines for Opioid Substitution Treatment in New Zealand 2008 3
2 Entry into Opioid Substitution Treatment Services 2. Assessment and suitability The comprehensive assessment for a client s/tangata whai ora s suitability for OST should start within two weeks of the client/tangata whai ora presenting or being referred to the specialist service. The assessment must be carried out by an appropriately trained and supervised clinician. Once a client/tangata whai ora is assessed as being suitable for OST, treatment should begin as quickly as possible (that is, within two weeks). The goals of the initial comprehensive assessment are to: facilitate client/tangata whai ora engagement in the treatment determine the client/tangata whai ora s suitability for OST (Note: A client s/tangata whai ora s use of other substances should not be a sole exclusion criteria) assist the client/tangata whai ora to make informed decisions about the treatment document an initial treatment plan that is agreed to by the client/tangata whai ora. The initial comprehensive assessment should include details of the client s/tangata whai ora s: reasons for and expectations of treatment alcohol and other drug-use history (including tobacco, and prescribed drugs); current use (including signs of intoxication, withdrawal, and physical evidence of past or current drug use, such as needle marks and associated bruising) past and present risk-taking behaviours (for example, sharing of injecting equipment, excessive and unsafe alcohol and other drug use, unsafe sexual practices) medical history (including alcohol and other drug-related accidents, head injuries, overdoses, significant illnesses or hospital admissions, contraception, dental problems, cardiac risks, current GP and current medication) mental health and psychological history (including previous mental health and alcohol and drug assessments and treatments and current psychological and mental health/psychiatric problems/disorders that may need referral for further assessment or intervention) risk of suicidality or other possible acts of harm to themselves or others or from others (including domestic violence) (note: A risk management plan may need to be developed if any such events are revealed) relevant legal history family/whānau history (including family history of alcohol and other drug use, medical problems including any cardiac problems, sudden deaths or mental health problems) and current relationships (including length of relationship, current status and stability) personal developmental history (including any history of childhood abuse; current social networks, social and role functioning (for example, employment/parenting) and particular strengths; as well as any educational or employment-related requirements). 4 Practice Guidelines for Opioid Substitution Treatment in New Zealand 2008
The assessment should also include: details of any restriction notices that apply under section 25 of the Misuse of Drugs Act 1975 or section 49 of the Medicines Act 1981 a record of any treatment options discussed with the client/tangata whai ora and assessed as being inappropriate or declined a diagnosis (note: A client/tangata whai ora must meet the diagnostic criteria for opioid dependence, such as those outlined in the DSM IV and ICD-10, to be suitable for OST) investigations, including a urine drug screen (to confirm level and nature of current use) and blood tests (for example, for liver function) and other relevant physical health checks). Wherever possible, (with consent from the client/tangata whai ora) corroborative evidence from support people (including family/whānau and significant others) should be obtained. Extra information may be collected in ongoing assessments and reviews so that more comprehensive treatment plans can be developed. The initial assessment is an important opportunity to build a therapeutic relationship, and clinicians need to take a non-judgemental and empathetic approach in all assessment situations. The client/tangata whai ora and their support people should be invited and encouraged to participate actively in treatment decisions from the start. The client/tangata whai ora needs to understand what is offered in the OST and the reasoning for all treatment options. The true identity of the client/tangata whai ora must be confirmed against, for example, their passport, driver s licence or birth certificate. Care should be taken to ensure that the client/tangata whai ora is not receiving any other opioid treatment or drug treatment that could potentiate increase the effect of the prescribed dose of methadone or other opioid substitute. Information (both written and oral) about treatment options and the side effects of any proposed medication should be given to the client/tangata whai ora, and relevant support people, at the time of assessment. The expectations and processes for transfer to an authorised or approved (also referred to as gazetted) medical practitioner should be clearly explained to the client/tangata whai ora when they are assessing OST as a treatment option. Informed consent will need to be gained at every stage of the treatment process (see 2.4 Informed Consent and Treatment Information). 2.2 Delaying entry to opioid substitution treatment If there is to be a delay in a client/tangata whai ora receiving OST, the specialist service will need to provide the client/tangata whai ora with advice, support and information on non-pharmacological alternatives to OST; refer them back to, or on to, a specialist alcohol and other drug treatment service who is able to undertake these roles; or facilitate the provision of an interim methadone prescribing programme. (See National Guidelines: Interim methadone prescribing at www.moh.govt.nz) Practice Guidelines for Opioid Substitution Treatment in New Zealand 2008 5
It is critical that the client/tangata whai ora be told how long they may need to wait for entry to OST and how their situation will be monitored and reviewed. Specialist services must have strategies in place to keep waiting times to a minimum. Long waiting times are contrary to the intention and spirit of OST as a harm minimisation strategy. 2.3 Special client groups 2.3. Priority admissions When a client/tangata whai ora is assessed as being suitable for OST, entry into a treatment programme should not be delayed. If delays are unavoidable, clients/tangata whai ora with certain conditions and/or in certain situations might be eligible for priority access based on the risks if they were not to receive treatment, but each case should be considered on its own merit. Such clients/tangata whai ora include: stabilised clients/tangata whai ora transferring within New Zealand those on OST programmes overseas who are returning home to New Zealand pregnant opioid-dependent women and their opioid-dependent partners those who have care of children, especially children under five years of age, or those who have sole responsibility for the children those with serious medical conditions, such as HIV/AIDS, and their opioid-dependent partners hepatitis B carriers (HbsAg, HbeAg positive, or HbeAg negative but HBV DNA positive) and their opioid-dependent partners those with co-existing serious psychiatric disorders those who are partners of clients/tangata whai ora who are also dependent on opioids those on interim methadone prescribing programmes who are likely to go to prison those who have relapsed after coming off OST those who have been released from prison and are seeking to re-engage and who are known to the specialist service. 2.3.2 Clients/tangata whai ora under 8 years of age OST should not be precluded on the grounds of age alone. Parental/caregiver consent to treatment is not required if the client/tangata whai ora is able to understand the reasons for OST and the process and risks associated with the treatment and agrees to that treatment. However, parental/ caregiver support should be sought, where appropriate, for those clients/tangata whai ora who are under 18 years of age, and in all cases, the consent process should be careful and fully documented. Children under 16 years of age who are being considered for OST require their assessment to be supported by an opinion from an addiction medical specialist or child and youth psychiatrist. Such clients/tangata whai ora should be treated in a service where the clinicians are skilled in both the youth and addiction areas. Clients/tangata whai ora under 18 years of age should receive the same level of treatment offered to adults (including dose and duration of treatment), and prescribers should follow the principles and requirements outlined in these guidelines. 6 Practice Guidelines for Opioid Substitution Treatment in New Zealand 2008
Buprenorphine may be preferred over methadone for the treatment of clients/tangata whai ora under 18 years of age because it has a lower risk of harm in overdose and less severe withdrawal symptoms. 2.4 Informed consent and treatment information Before consenting in writing to take part in a planned OST, and providing written consent to the immediate treatment plan the client/tangata whai ora must first be informed of and provided with written information on: their rights as well as their obligations/responsibilities to the service (see 9.5 Rights of the client/tangata whai ora) the effects (benefits, side effects, limitations) of methadone or any other opioid substitution medicine the potential effects of methadone, or another opioid substitute medicine, and the comparative risk of this compared with continuing injecting and illicit drug use in pregnancy the potential effect of methadone or other opioid substitution medicine on activities such as driving and operating machinery (see 2.5 Fitness to drive and operate machinery) the interactive effects of methadone, or another opioid substitution medicine, with alcohol and other drugs the possible need to have an ECG before commencing treatment, or while on OST, to establish the client s/tangata whai ora s QTc (see Appendix 1: Glossary) and risks of QTc prolongation. the process for making complaints (see 9.6 Complaints procedure) the availability of consumer and peer support services. Informed consent should be viewed as an ongoing process. Clients/tangata whai ora need to be fully informed throughout the OST of any changes in service delivery and any proposed changes to their treatment plan. 2.5 Fitness to drive and operate machinery Methadone and buprenorphine may affect the capacity of clients/tangata whai ora to drive or operate machinery particularly: during the first 7 to 10 days of OST for 3 to 4 days after any dose increases when undergoing a rapid reduction of opioid substitution medicine when the client/tangata whai ora uses alcohol or other drugs including some prescribed medications when the client/tangata whai ora has a medical or psychological condition that is likely to contribute to impairment. Specialist service clinicians and prescribing doctors should advise a client/tangata whai ora of any possible effects and the degree of associated risk before the client/tangata whai ora enters OST, when their dose is increased and when they are known to be using or have been prescribed other drugs that could contribute to impairment or alter the metabolism of the opioid substitute medicine. Any advice given should be documented on the client s/tangata whai ora s records. Practice Guidelines for Opioid Substitution Treatment in New Zealand 2008 7
It is safer for a client/tangata whai ora to avoid driving a car or operating machinery until they are on a stable dose of methadone or buprenorphine. Once stabilised and with unchanging doses, it is unlikely that their driving skills will be impaired unless they have been consuming other substances. If a client/tangata whai ora is considered medically unfit to drive, the prescribing doctor must advise them of this both verbally and in writing. If the risk is unlikely to be of short duration and the client s/tangata whai ora s other substance use or psychological function indicates that they may not follow the doctor s advice, the prescribing doctor (after consulting the multidisciplinary team) must notify New Zealand Transport Agency (formerly Land Transport NZ). 2.6 Contraindications to opioid substitution treatment Relative contraindications Severe hepatic or respiratory insufficiency. General contraindications Inability to give informed consent Lack of evidence of opioid dependence. Precautions Medical conditions: caution should be taken when prescribing methadone and buprenorphine to clients/tangata whai ora with QTc prolongation, acute asthma, acute alcoholism, a head injury and raised intracranial pressure, ulcerative colitis, biliary and renal tract spasm; to clients/tangata whai ora who are prescribed monoamine oxidase inhibitors or within 14 days of stopping treatment. Specific contraindications to buprenorphine Pregnancy and breastfeeding: currently there is increasing support for the use of buprenorphine (without naloxone) by clients/tangata whai ora who are pregnant or breastfeeding. The combination product is not recommended for use in pregnant or breastfeeding clients/tangata whai ora due to the lack of knowledge of the effect of naloxone (see 7.12.3 Buprenorphine in pregnancy and breastfeeding). 2.7 The treatment plan Any assessment of a client/tangata whai ora must address the full gambit of that person s life. Treatment plans must therefore address a full range of social issues including housing, education and working aspirations, legal issues and health improvement. The specialist service will develop a written treatment plan in collaboration with the client/tangata whai ora and where possible their support people (significant others, family/whānau). The plan should state the client s/tangata whai ora s problems as well as their strengths and treatment goals, including a suggested timeframe for achieving the goals. It should also give consideration to other appropriate programmes (both residential and non-residential) that the client/tangata whai ora may be involved in and links that could be made to facilitate co-ordination and continuity of care and ensure that the treatment integrates smoothly with these existing programmes. The specialist service will need to record that the initial treatment plan and any subsequent treatment plans have been negotiated with, and agreed to by, the client/tangata whai ora (with 8 Practice Guidelines for Opioid Substitution Treatment in New Zealand 2008
participation from their support people, if possible) and that the client/tangata whai ora has been offered a copy of the treatment plan, and all treatment plans need to be signed and dated by the client/tangata whai ora to acknowledge this understanding and acceptance of the plan. The plan must be regularly updated (that is, six-monthly), or as required, by the key worker in collaboration with the client/tangata whai ora and, where possible, their support people and others involved with their treatment. The treatment plan may be shared with other parties (for example, probation officer, pharmacist, GP, prison medical staff) with the client s/tangata whai ora s agreement, and written consent. Practice Guidelines for Opioid Substitution Treatment in New Zealand 2008 9
3 Commencing Treatment 3. Induction The first dose in OST should aim to achieve an effective level of comfort, both physical and psychological, while minimising the likelihood of overdose. Frequent clinical observation needs to occur to ensure the client s/tangata whai ora s safety during the induction process. There is considerable research evidence that suggests that the first two weeks of methadone treatment is a time of increased risk of death due to methadone toxicity. Deaths in the first two weeks of OST have been associated with treatment doses in the range of 25 100 mg of methadone per day, with most deaths occurring in the 40 60 mg range (see 7.7 Management of Overdose). After the first two weeks, the risk of death due to opioid overdose during treatment falls to very low levels. As opioids induce respiratory depression and hypoventilation, clients/tangata whai ora should be cautioned against and provided with written information about using illicit/other opioids or sedative drugs such as benzodiazepines and alcohol concurrently while waiting to reach an adequate opioid substitution dose because such drugs can increase this effect. 3.2 The starting dose of methadone Initial doses of methadone in OST should be based on the client s/tangata whai ora s treatment aims; history of quantity, frequency and route of administration of opioids; and use of other central nervous system depressants. Treatment should also take into account the client s/tangata whai ora s hepatic and renal functioning. In general, the initial daily dose will be in the range of 10 40 mg. The first dose of methadone should never be higher than 40 mg. Following the first methadone dose, the key worker or doctor should observe the client s/tangata whai ora s response to the dose after 30 minutes and again three or four hours after the dose has been taken (at peak plasma level concentration) to assess for signs of toxicity or withdrawal. For this reason, the first dose should be administered in the morning. Treatment should be started early in the week so that the maximum serum level at day three or four is reached when monitoring is available (such monitoring is generally not available in the weekend). It is recommended that the methadone dose not be increased for the first three to four days as methadone accumulation is significant and poses a considerable risk if doses are increased too rapidly. The client/tangata whai ora will need to be monitored again three to four hours after the third or fourth dose to exclude the risk of intoxication in relation to the peak plasma concentration. By the fourth day, the client/tangata whai ora should be close to achieving a steady state methadone level. In rural areas, a pharmacist may be appropriate to conduct this monitoring. 0 Practice Guidelines for Opioid Substitution Treatment in New Zealand 2008
Where doses need to be increased in response to withdrawal reactions, the increment of increase should be no more than 5 10 mg at a time and not more often than every three to four days. Any dose change in this or later phases of OST should be organised whenever possible in face-to-face discussion with the client/tangata whai ora in order to mitigate the possibility of distrust or misunderstanding developing and to maintain an effective therapeutic relationship. Maintaining a quality therapeutic relationship with clients/tangata whai ora has been shown to increase client/tangata whai ora retention on an OST programme and is associated with positive treatment outcomes (Deering 2007a; Ball and Ross 1991; Magura et al 1999). 3.3 The starting dose of buprenorphine Buprenorphine is a partial agonist; this means that it can prevent a concurrently administered agonist drug from producing its full agonist effect (see Appendix 3: Pharmacology and Pharmacokinetics of Methadone and Buprenorphine). Buprenorphine has long-lasting action (Raisch et al 2002), resulting in minimal blood level fluctuations and prevents opioid withdrawal symptoms when taken regularly. It can be provided in larger initial doses than the full agonists such as methadone. Moreover, buprenorphine is both safe and effective when rapidly increased to higher dose levels in response to reactions (up to 16 mg by day three) and is recommended for extending the therapeutic effect and encouraging a client s/tangata whai ora s retention on the treatment programme (see 10.2 Buprenorphine). Since buprenorphine will displace other opioids from opioid receptors but has less intrinsic opioid activity, it can precipitate withdrawal symptoms if given while other opioids are active. Thus, the first dose of buprenorphine should not be given until objective signs of opioid withdrawal are clearly seen. This is likely to be: 8 12 hours after the client s/tangata whai ora s last dose of intravenous morphine or homebake 12 14 hours after oral use of morphine or poppy-seed tea 24 hours after a dose of less than 40 mg of oral or intravenous methadone between 36 and 48 hours after a dose of between 40 and 60 mg of oral or intravenous methadone. The first dose will usually be from 4 8 mg of buprenorphine. This may be repeated if assessment four hours later suggests that withdrawal is persisting. It is recommended that the first dose be given early in the day so that any withdrawal symptoms that occur can be managed. Splitting the first daily dose into twice-daily or three-times-daily doses reduces the chance of precipitated withdrawal. The prescribing doctor or another member of the specialist service team should monitor the client/ tangata whai ora regularly; at least daily for the first three days, then every two to four days during the induction phase. Practice Guidelines for Opioid Substitution Treatment in New Zealand 2008
The dose should be titrated according to the client/tangata whai ora s: reported intoxication, withdrawal and cravings over the preceding 24 hours additional drug use, and reported reason for this use experience of side effects or other adverse effects adherence to the dosing regimen satisfaction with the dose. 3.4 Induction and blood-borne viruses A significant number of injecting drug users are infected with hepatitis B or C, but this seldom poses problems during induction unless the client/tangata whai ora has advanced liver disease, detectable at clinical examination. Clients/tangata whai ora with end-stage liver disease should only be commenced on methadone or buprenorphine with extreme care and should be referred for a specialist opinion. Many HIV medications interact with methadone and buprenorphine, and doses may need to be adjusted accordingly. Consultation with the HIV medication prescriber is recommended. 3.5 Stabilisation Stabilisation is a multi-faceted process that allows the client/tangata whai ora to make the best use of OST. The decision about what level of stabilisation is most appropriate for an individual needs to be made jointly by the prescriber, key worker (if different) and the client/tangata whai ora. During the first two weeks of treatment, the aim is to stabilise the client/tangata whai ora so that they do not oscillate between intoxication and withdrawal. However, the client/tangata whai ora will not necessarily reach a stable dose during this period. Further dose adjustments may be required after the client/tangata whai ora has been initially stabilised. At a minimum, stabilisation would mean that the client/tangata whai ora is comfortable on a consistent regular dose without the need for constant dose changes and review and is able to work consistently towards agreed goals. For some clients/tangata whai ora, this will take a considerable time to achieve, and they may need significant input from the specialist service. Other factors to consider when assessing stability include assessing the client s/tangata whai ora s: progress towards meeting treatment goals reduction or cessation of harmful or hazardous uses of other drugs (prescribed and nonprescribed), including alcohol attendance at the specialist service and/or other essential appointments stability within their social roles (that is, housing, employment, parenting, education) stability of their relationships with others, partners, children and other providers co-existing mental or physical health problems, if any, and whether these are well managed reduction or cessation in involvement in drug-related criminal offending responsible management of dispensed medicine. 2 Practice Guidelines for Opioid Substitution Treatment in New Zealand 2008
Table : A comparison of induction with buprenorphine and induction with methadone Pharmacology and Pharmacokinetics Induction Methadone Long half-life, full agonist. Doses that exceed an individual s tolerance can result in respiratory depression and death. High bioavailability. Doses above 30 mg may be fatal in opioid-naive clients/tangata whai ora. Should not start if the client/tangata whai ora appears intoxicated or sedated with opioids or other CNSdepressant drugs because of the risk of enhancing respiratory depression. Significant increases in plasma levels of methadone during the first days of treatment. Supervised dosing required at intervals during the first week to check for opioid toxicity. No risk of precipitated withdrawal. Methadone may be preferable to buprenorphine for clients/tangata whai ora who have severe pain. First doses in the range 10 40 mg. Dose at the end of the first week not usually > 50 mg. Buprenorphine Long half-life, partial agonist. High affinity to, and slow dissociation from, receptors. Plateau on opioid effects (including respiratory depression) even with increasing doses. Poor oral availability necessitating a sublingual formulation. Precipitated withdrawal risk: should only start once there is evidence of withdrawal (see 3.3 The starting dose of buprenorphine). High-dose rapid induction is safe and effective. Rapid induction produces side effects in some client/tangata whai ora: dizziness, nausea, sedation and headaches are common. Safer in overdose than methadone if combined with other CNS-depressant drugs, such as other opioids or benzodiazepines, but a fatal overdose in combination can still occur. Stabilisation can be achieved more rapidly than with methadone. Higher doses have a longer duration of action, permitting less-than-daily dosing once stabilised. Adapted from table 4.1.3 Clinical Guidelines for Methadone and Buprenorphine Treatment of Opioid Dependence NSW Opioid Treatment Programmes (NSWH 2007). Practice Guidelines for Opioid Substitution Treatment in New Zealand 2008 3
4 Ongoing Opioid Substitution Treatment Once stabilisation on methadone is achieved, individualised goals focussed on promoting wellness, client self-management and community participation within a family and whānau context should assume a high priority (Deering 2007b). 4. Methadone doses Optimal methadone doses will generally be in the range of 60 120 mg daily. Sometimes higher doses (or, less commonly, split doses see 7.4 Split methadone dosing) may be required to achieve stabilisation. In such instances, serum methadone level monitoring (see 7.3 Measuring methadone serum levels) and specialist service consultation, in addition to consultation with the client/tangata whai ora and, as appropriate, their support people and pharmacist, should be considered. In some cases, lower doses may be adequate. Whatever the case, the dose should be sufficient to ensure that the client/tangata whai ora is clinically stable, can function adequately in their social roles, experiences the minimum of withdrawal symptoms and is retained in treatment. Any changes in dose should always be negotiated with the client/tangata whai ora. Doses that are to be consumed at a pharmacy must be swallowed in front of the pharmacist or pharmacy technician to minimise the risk of diversion. Care should be taken to minimise the possibility of takeaway doses of methadone (any dose that is not consumed under observation) being sold, used against medical advice (for example, doubling up or injecting) or used by others. 4.2 Buprenorphine doses The effective daily dose range of buprenorphine for most clients/tangata whai ora is 12 24 mg/day. However, there is significant individual variation in dose requirement. While a dose of 4 mg/day is rarely effective, some clients/tangata whai ora can be satisfactorily maintained on 8 mg/day. Daily dosing is recommended for the initial period of stabilisation. Once stabilised, a significant proportion of clients/tangata whai ora can be adequately maintained by receiving a dose every alternative day and some every third day. Before a trial of less-than-daily dosing is undertaken, the client/tangata whai ora would need to demonstrate stability on daily dosing of buprenorphine for at least two weeks. 4.3 Maximum doses Because of individuals variability in pharmacokinetics and clinical responses, some clients/tangata may benefit from a daily dose of methadone above 150 mg or buprenorphine above 32 mg. A prescribing doctor should only prescribe higher doses after careful consideration and in consultation with the multidisciplinary team. 4 Practice Guidelines for Opioid Substitution Treatment in New Zealand 2008
4.4 Transferring from methadone to buprenorphine See also 10.2 Buprenorphine. Transferring previously stable clients/tangata whai ora from methadone to buprenorphine carries a risk of destabilisation. Appropriate monitoring and support should be provided and transfers need to be well planned. If the client/tangata whai ora becomes destabilised, it may be best to return them to methadone treatment (Lintzeris et al 2006). When methadone clients/tangata whai ora take a dose of buprenorphine, the buprenorphine displaces methadone from the opioid receptors causing a net reduction in opioid activity. To minimise the chance of precipitated withdrawal, clients/tangata whai ora should be on a methadone dose of less than 40 mg (ideally 30 mg or less) for at least one week before starting a buprenorphine treatment. Transition to buprenorphine from methadone doses greater than 60 mg are generally not recommended. It is recommended that any client/tangata whai ora experiencing difficulty in the transition to buprenorphine be admitted as an inpatient with the prescription of symptomatic withdrawal medication, including clonidine. The first dose of buprenorphine should be administered only when the client/tangata whai ora experiences mild to moderate observable opioid withdrawal signs. Usually this will occur at least 24 hours after the last methadone dose (see 3.3 The starting dose of buprenorphine). On day two in the transition to buprenorphine, if the client/tangata whai ora has experienced no precipitated withdrawal, rapid titration of buprenorphine should commence. Table 2: Conversion rates for low-dose methadone transfer Last oral methadone dose Initial buprenorphine dose 30 mg or greater 4 mg plus 0 4 mg plus 0 4 mg Less than 30 mg 2 mg plus 0 4 mg plus 0 4 mg Source: Lintzeris et al 2006 4.5 Transferring from buprenorphine to methadone A transfer from buprenorphine to methadone may be appropriate when: the side effects of buprenorphine are intolerable for the client/tangata whai ora the client s/tangata whai ora s response to the buprenorphine treatment is inadequate. Clients/tangata whai ora should be stabilised on daily doses of buprenorphine before transfer to methadone. If possible, the daily buprenorphine dose should be reduced to 16 mg or less for several days before transfer. Methadone can be commenced 24 hours after the last dose of buprenorphine. The first dose of methadone should not exceed 40 mg. Clients/tangata whai ora who are transferring from lower doses of buprenorphine should receive lower doses of methadone (NSWH 2007). Practice Guidelines for Opioid Substitution Treatment in New Zealand 2008 5
4.6 Treatment reviews 4.6. Reviews by the prescribing specialist service doctor Clients/tangata whai ora who are receiving OST must be seen by the prescribing doctor or their locum before receiving the initial dose and at least once during the first seven days of treatment. During dose increases, more frequent observation is advisable. The prescribing doctor or a specialist service nurse should see the client/tangata whai ora regularly during the first three months of the stabilisation phase or until a stable and clinically effective dose is achieved. The frequency of review will be determined by the stability and other specific needs of the client/ tangata whai ora. Once dose stabilisation is achieved, the prescribing doctor can be expected to see the client/tangata whai ora at least every three to six months. Where possible, such reviews should also involve the key worker. 4.6.2 Reviews by the key worker Clients/tangata whai ora who are receiving OST should be seen by their key worker at least once a week for the first month or until a stable dose and satisfactory life situation is achieved. However, clients/tangata whai ora who are not progressing well (medically or psychologically or who are at risk of relapse) will benefit from more frequent and intensive intervention. Once a stable dose has been achieved, the key worker should see the client/tangata whai ora at least once a month for the second and third months and at least once every three months thereafter. Depending on the individual s needs, the key worker may see clients/tangata whai ora individually or in groups on a monthly basis or more often as required. Regular monitoring sessions would be expected to include a review of progress in relation to the short-term and longer-term treatment plan and an updated assessment of risk. The review may also include (but is not limited to): a review of how the client/tangata whai ora is functioning in their social role and their employment/education status and aspirations a discussion of links with other health and social service providers a discussion of ongoing substance use and misuse (including alcohol and tobacco) a discussion of the results of any urine drug screens consideration and review of dose adjustments and takeaway arrangements consideration of lifestyle and high-risk behaviour changes, including lapses and relapses a referral for the review of medical issues where needed a review of the client s/tangata whai ora s mental state and management of co-existing mental health disorders a review of whānau ora the client s/tangata whai ora s relationship with their family/ significant others information and/or referral to self-help groups and other support and ancillary services (that is, peer support workers) 6 Practice Guidelines for Opioid Substitution Treatment in New Zealand 2008